Flexible Disposable Surgical Port

ABSTRACT

A surgical apparatus for introduction of laparoscopic instruments into an anatomical cavity through tissue at an entry site. The apparatus includes a body with a frustoconical-shaped wall. The body defines an interior cavity, an open bottom, and a substantially closed top wall with openings from which a plurality of ports extend upward therefrom. The ports are adapted to receive the laparoscopic instruments for introduction through the interior cavity and open bottom of the body into the anatomical cavity. In the preferred embodiment, the frustoconical-shaped wall of the body is placed through an incision in the umbilicus. In one aspect of the invention, the body is a unitary one-piece molded structure. A reinforcing belt or plate formed from a relatively hard material can be integral to the body, and separately formed port caps each having a septum may be bonded to the ports.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority benefits from U.S. Provisional PatentApplication No. 61/094,706, filed Sep. 5, 2008, and from U.S. patentapplication Ser. No. 12/468,219 filed May 19, 2009, the contents of bothof which are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention broadly relates to surgical ports. The invention moreparticularly relates to surgical ports for abdominal surgery, althoughit is not limited thereto.

2. State of the Art

Endoscopic or laparoscopic surgery has existed for over two decades. Thesurgery usually involves making three small incisions in the abdomen,into which endoscopic surgical tools such as scissors, graspers etc.,are introduced through trocar sleeves. Surgical trocars generallyinclude a cylinder with a sharply pointed end and a sleeve around thecylinder. The pointed end of the cylinder is used to make a hole in theabdomen and facilitates entry of the sleeve into the body cavity. Whenthe cylinder is removed from the sleeve, the sleeve provides a portthrough which instrumentation may be introduced.

Instrumentation for laparoscopic surgery may include an insufflationmeans (usually a carbon dioxide source and tubing), a fiber optic light,a forceps (grasper), a scissors, a stapler, a clip applier, a videocamera, etc., depending upon the nature of the surgery. The proximal endof the trocar may include one or more valves such as flapper valves orwasher valves which are attached to the cylinder for preventing escapeof gas (desufflation) from the abdominal cavity as the instrumentationis placed into and removed from the trocar sleeve.

SUMMARY OF THE INVENTION

The present invention provides a flexible surgical port device which canbe placed through an incision in the belly button (umbilicus). Thedevice of the invention incorporates three or more ports in the deviceso that laparoscopic surgery requiring three ports can be conductedthrough the device without the necessity of making additional incisionsin the abdomen.

According to an aspect of the invention, a molded flexible elasticdisposable port includes a hollow generally frustoconical body having anopen bottom and a generally closed top defining at least three andpreferably four port holes, and at least three and preferably four portsintegral with the body, including three ports with valves for receivingsurgical instruments, and one for receiving an insufflation sourceextending upwards from the top which are in fluid communication with theport holes. In use, a plurality of endoscopic instruments are passedthrough the ports and through the central cavity defined by thefrustoconical body into the abdominal cavity to allow for manipulationof the instruments inside the abdominal cavity.

According to one aspect of the invention, the flexible disposable portis a single piece which is molded from an elastic material, and valvesare formed in the elastic material.

According to another aspect of the invention, the flexible disposableport is an insert molded piece formed of an elastic molded material andhaving a belt or plate formed from a relatively hard material insertedtherein, where the valves are formed in the molded elastic material.

According to an additional aspect of the invention, the flexibledisposable port is a molded piece having a hollow generallyfrustoconical body having an open bottom and a generally closed topdefining at least three and preferably four port holes and at leastthree and preferably four ports integral with the body, and a cap whichadheres to the ports and provides septa through which endoscopicinstruments are passed.

According to a further aspect of the invention, the flexible disposableport formed of an elastic molded material is provided with a compressionband around each septum to impart a continuous radial compressive forceon the septum.

According to yet a further aspect of the invention, the flexibledisposable port including the port valves is molded from a materialhaving a Shore Hardness of between 30A and 65A, a tensile strength ofgreater than 3 MPa, a tear strength of greater than 20 KN/m, and anelongation percentage at break of greater than 600%.

It will be appreciated that the umbilicus is a unique structure as alarge incision can actually be hidden in it as it is already just a bigscar. In addition, it stretches more than most tissue. For example, onecan make a 15 mm incision in the umbilicus and stretch the opening toapproximately 30 mm. The fascia underneath the umbilicus may be moretense than the umbilicus tissue. However, the fascia can be cut to allowa larger opening without concern of a visible cosmetic scar.

Objects and advantages of the invention will become apparent to thoseskilled in the art upon reference to the detailed description taken inconjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is perspective view of a first embodiment of a flexible portdevice in accordance with the present invention.

FIG. 2 is a top view of the device of FIG. 1.

FIG. 3 is a bottom view of the device of FIG. 1.

FIG. 4 is an enlarged view of the suture catch of the device of FIG. 1.

FIG. 5 is a perspective view of a second embodiment of a flexible portdevice in accordance with the present invention.

FIG. 6 is a top view of the device of FIG. 5.

FIG. 7 is a bottom view of the device of FIG. 5.

FIG. 8 is a sectional view through the device of FIG. 5 along line 8-8of FIG. 6.

FIG. 9 is a perspective view of a third embodiment of a flexible portdevice in accordance with the present invention.

FIG. 10 is sectional view of the device of FIG. 9.

FIG. 11 is a perspective view of a fourth embodiment of a flexible portdevice in accordance with the present invention.

FIG. 12 is a side view of the device of FIG. 11.

FIG. 13 is a top view of the device of FIG. 11.

FIG. 14 is a bottom view of the device of FIG. 11.

FIG. 15 is a perspective view of a plate molded into the device of FIG.11.

FIG. 16 is a two-dimensional cross-sectional view of the device of FIG.11 along line B-B shown in FIG. 13.

FIG. 17 is a three-dimensional cross-sectional view of the device ofFIG. 11 along line C-C shown in FIG. 13.

FIG. 18 is a perspective view of a fifth embodiment of a flexible portdevice in accordance with the present invention.

FIG. 19 is a cut off cross-sectional view of the device of FIG. 18.

FIG. 20 is a perspective view of the device of FIG. 5 shown sutured inplace in an abdomen with tools extending through two of the ports.

FIG. 21 is a graph comparing the sliding force required for alaparoscopic instrument through lubricated and non-lubricated SIBSvalves.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A first embodiment of a flexible disposable port 100 in accordance withthe present invention is shown in FIGS. 1-4. The port 100 is formed of asingle molded piece of flexible material and includes a flexible topwall 111 having three working ports 113, an insufflation port 114 (forinsufflation/desufflation) and suture retention means 115 integraltherewith and extending outwardly therefrom, and a hollow frustoconicalbody 122 which is open at the bottom and is closed by the flexible topwall 111.

The working ports 113 each have an inner diameter of approximately 7 mm,although ports of different diameters can be utilized. As will bediscussed hereinafter, the working ports are provided with seals orvalves which are designed to seal about nominally 5 mm laparoscopictools. The inner diameter of the insufflation port 114 is approximately3-5 mm, and insufflation port 114 is adapted to receive a tube (notshown) which is coupled to a source of gas

As seen best in FIG. 2, three suture retention means 115 are providedand are spaced at one hundred twenty degree intervals, although adifferent number of suture retention means may be utilized and/ordifferent spacings could be used. As seen in FIG. 4, each of the sutureretention means 115 defines a slot 128 at its base. The slot is providedsuch that a suture may be snagged in the slot between the top wall 111and the suture retention means 115.

Each of the working ports 113 can be fitted with a valve to preventpressure loss when an instrument is removed from the port. In theillustrated embodiment, the entrance to the working ports 113 are fittedwith a flexible O-shaped seal 136, which is preferably realized as athin stretchable membrane having an open circular hole (approximately 4mm in diameter) in its center as shown in FIGS. 1-3. The O-seal 136 ispreferably molded as part of the port 100 and configured to seal againstan instrument passing therethrough during use. The O-seal 136 may beused in conjunction with a flapper valve (not shown) as is known in thetrocar arts. Alternatively, if desired, the valve may be formed as partof the molded port 100 by causing the top of each port 113 to be closed,and then by slitting the top to generate a slit valve (e.g., an X, Y, Ior arcuate slit). As another alternative, a tricuspid valve or aduck-bill valve may be formed as part of the mold or may be separatelyprovided and fit to the ports as is well known in the industry. In yetanother alternative embodiment, little plugs which can fit into theports 113 and having associated arms (not shown) attached to top wall111 can be molded as part of the port 100 and can be used to close ports113 when tools are not extending through the ports 113.

As shown in FIG. 3, the hollow frustoconical body 122 extends distallyfrom the perimeter of the top wall 111 and is configured for insertioninto a single incision in the umbilicus. The frustoconical body 122 hasa tapered sidewall 142 which defines a central cavity 152 with anopening 153 opposite the top wall 111. In the shown embodiment, thetapered sidewall 142 includes circumferential grooves or dents 159 whichare spaced apart along the exterior surface of the tapered sidewall 142.The grooves 159 can assist a surgeon in cutting or otherwise trimmingthe tapered sidewall 142 to a desired length with a scissors or sharpscalpel if so desired.

FIGS. 5-8 show an alternate embodiment of a port device 200. In thealternate embodiment of FIGS. 5-8, like numerals (increased by 100) areused to refer to the structural elements that are similar to those ofthe embodiment described above with respect to FIGS. 1-4. In thisembodiment, the working ports 213 of port 200 have different diameters.For example, as shown, the working port 213A is larger in diameter thanthe working ports 213B and 213C. In the preferred embodiment, port 213Ais approximately 12 mm in diameter to accept a 10 mm-12 mm diameterstapler, clip applier, or other nominally 10 mm tools, while ports 213Band 213C are 7 mm in diameter for smaller (5 mm diameter or smaller)instruments such as scissors and graspers. Each of the working ports213A, 213B, 213C is shown molded with a membrane 217 which can be slitto form a slit valve (e.g., an X or Y slit) or may be left as a blankand punctured by instrumentation at the time of use. Alternatively, eachport may be molded with a tricuspid or duck-bill valve, or the O-shapedseal having an open circular hole in its center as shown in the firstembodiment. As another alternative, each port may be fitted with a valve(not shown) to prevent pressure loss (desufflation) when an instrumentis removed from the port.

The port 200 also preferably includes a plurality of suture retentionmeans 225 (for example, two shown) disposed about the periphery of thetop wall 211. The suture retention means 225 comprises a tab or ear thatextends radially outward beyond the perimeter of the top wall 211(preferably in or substantially parallel to the plane of the top wall asshown). The tab defines slots 229 that preferably extend parallel to thecentral axis 216 of the port 200. The slots 229 are disposed radiallyoutward from the perimeter of the top wall 211 and tapered sidewall 222of body as best shown in FIGS. 6 and 7. The slots 229 are adapted tograb or otherwise hold sutures inserted therein for fixation of the port200 during use.

FIGS. 9 and 10 show an alternate embodiment of a port device 300. In thealternate embodiment of FIGS. 9 and 10, like numerals (increased by 200)are used to refer to the structural elements that are similar to thoseof the embodiment described above with respect to FIGS. 1-4. In theembodiment of FIGS. 9 and 10, a suture plate 370 has a circular portion371 which is fitted over top wall 311 of the port device 300. The plate370 has holes to accommodate the working ports 313A, 313B, 313C, and theinsufflation port 314. The plate 370 also includes suture ears 326 whichextend outwardly from the circular portion 371 and are connected to thecircular portion 371 by a neck portion 372. The suture ears 326, necks372, and circular portion 371 define suture grooves 327 which receivesutures for suturing the device 300 to tissue adjacent the entrancesite. The suture plate 370 can be made substantially rigid when formedfrom a metal, polyoxymethylene such as Delrin, polycarbonate,polyurethane, acrylics, acrylates, poly(acrylonitrile-butadiene-styrene)which is commonly referred to as ABS, etc. Suture plate 370 can beadhered to surface 311 or held in place by mechanical locking means (notshown). When substantially rigid, the suture plate 370 will not bend orstretch much when held down with sutures. Alternatively, the sutureplate 370 can be made more flexible when formed from a more flexiblematerial.

The port device 300 of FIG. 9 includes a reinforcement belt 380 (FIG.10) placed in the upper section of the flexible tapered wall 342 so asto reinforce the wall 342 to maintain it round when inserted into theumbilicus. The length of the reinforcement belt 380 can be 5% to 33% ofthe axial length of the tapered wall 342. The thickness of the belt 380is preferably between 0.5 mm and 1.5 mm. The belt 380 can beinsert-molded in place or placed in the taper after completion of thedevice 300. It can also be glued in place. It can also be appreciatedthat the thickness of the tapered frustoconical wall of any of theembodiments can be made thicker in the proximal area to accomplish thesame reinforcement purpose. Ribs, both circumferential and longitudinalcan be incorporated to function similarly.

FIGS. 11-17 show yet another embodiment of a port device 400. In thealternate embodiment of FIGS. 11-17, like numerals (increased by 300)are used to refer to the structural elements that are similar to thoseof the embodiment described above with respect to FIGS. 1-4. In thisembodiment, the working ports 413 of port 400 have the same innerdiameter (for example, 7 mm in diameter for smaller 5 mm diameterinstruments such as scissors and graspers). Each of the working ports413 is shown molded with a membrane 417 which can be slit to form a slitvalve (e.g., an X or Y slit) or may be left as a blank and punctured byinstrumentation at the time of use. Alternatively, each port may bemolded with a tricuspid or duck-bill valve, or the O-shaped seal havingan open circular hole in its center as shown in the first embodiment. Asanother alternative, each port may be fitted with a valve (not shown) toprevent pressure loss (desufflation) when an instrument is removed fromthe port.

The port 400 also preferably includes a reinforcement plate 480 (FIG.15) formed as part of the top wall 411 of the frustoconical body 422 asbest shown in FIGS. 16 and 17. The reinforcement plate 480 reinforcesthe tapered wall 442 of the body 422 to maintain it round when insertedinto the umbilicus. In the preferred embodiment, the plate 480 isrealized of a moldable or thermoformable polymeric material such aspolycarbonate, stiff polyurethanes, metal, polymethylmethacrylate(Plexiglas®), polyacetal (Delrin®), ABS, acrylics or other suitablematerial. The plate 480 is preferably insert molded in place orotherwise placed in position adjacent the top wall 411 of the body 422of the device 400. When insert molded, the material of the plate 480 isrequired to withstand the heat and pressure of the injection molding ofthe frustoconical body 422. The reinforcement plate 480 includes a firstset of through-holes 470 that are aligned to corresponding ports 413 andsized to accommodate the tool(s) inserted through the respectivecorresponding port 413 and through-hole 470. In the preferredembodiment, the through-holes 470 are oversized relative to the diameterof the corresponding port 413, and during insert molding, the materialthat forms the top wall 411 and ports 413 form a central opening insidethe oversized through-hole 470. This central opening matches (and isaligned to) the inside diameter of the corresponding port moldedthereabove. Also note that the plate 480 is preferably held in placeunder and adjacent to the top wall 411 of the body 422 by a ledge 481formed in the interior surface of the tapered sidewall 442 as shown inFIG. 17. Moreover, the material that is molded to form the top wall 411,sidewall 422 and ports 413 of the device 400 may be allowed toencapsulate the plate 480 by a thin layer 482 as shown in FIG. 17. Thereinforcement plate 480 operates a pivot point about which to pivot therespective tool passing therethrough. The reinforcement plate 480 alsopreferably includes a through-hole 473 aligned with the insufflationport 414 to allow for gas to pass between the insufflation port 414 andthe interior cavity 452 of the body 422. The plate 480 also preferablyincludes a second set of through-holes 474 that allows for inflow ofmaterial therein during insert molding to join the plate 480 to the topwall 411 of the body 422. The thickness of the plate 480 is preferablybetween 0.05 in and 0.25 in, and most preferably approximately 0.125in.±20%.

The plate 480 also has a plurality of suture ears 426 (for example, twoshown) which extend outwardly from the circular portion 471 and areconnected to the circular portion 471 by a neck portion 472. The sutureears 426, necks 472, and circular portion 471 define suture grooves 427(FIG. 15) which receive sutures. The suture ears 426 will not bend orstretch much when held down with sutures. The suture ears 426 extendradially outward beyond the periphery of the top wall 411 of the body422 such that suture grooves 427 are disposed about the periphery of thetop wall 411 of the body. The suture grooves 427 are adapted to grab orotherwise hold sutures inserted therein for fixation of the port 400during use. In the illustrative embodiment shown in FIG. 15, the plate480 has two suture ears 426 that are disposed diametrically apart.During use, the ears 426 are sutured to the incision and the ears 426joined through the plate 480 act as a rigid axle that allows the port480 to rock back and forth in the incision. This freedom of movementallows for greater control of the surgical tools.

FIGS. 18 and 19 show a presently preferred embodiment of a port device500. In the embodiment of FIGS. 18 and 19, like numerals (increased by100) are used to refer to the structural elements that are similar tothose of the embodiment described above with respect to FIGS. 11-17. Theport device 500 is substantially identical to port device 400 except forthe construction of the working ports 513 (and optionally theinsufflation port 514). Thus, a reinforcement plate 580 identical toplate 480 is provided under the top wall 511, with the reinforcementplate 580 having ears 526 extending outwardly therefrom, and the body522 with sidewall 542 and bottom opening 553 is identical. As a result,for purposes of brevity, all of the details of those aspects of the portdevice need not be repeated. However, the working ports 513 of portdevice 500 are constructed differently from the working ports 413 ofport device 400. In particular, as seen in FIGS. 18 and 19, extendingfrom top wall 511 (shown in FIG. 18 and not shown in FIG. 19) areworking port bases 584 which have a base section 584 a adjacent top wall511 having a first thickness and step down to a much narrower thicknessfor an upper section 584 b. Extending around the upper section 584 b isa cap 585 having a top septum 586 and a cylindrical wall 587 extendingdownward therefrom, and a base section 588. The cap 585 with the septum586 is preferably a one piece compression molded element. The top ofseptum 586 defines a central well 586 a. As seen in FIG. 19, the septum586 is also slit (from the bottom up) so that the slit 586 b extendsentirely through the septum in the central well area (slit 586 b beingshown as visible from the top in FIG. 18) but does not extend entirelythrough the septum beyond the central well area. In this manner, theseptum will seal around a tool shaft when a tool is inserted through theslit and well 586 a of the septum 586.

The cap 585 of the working port 513 is bonded to the working port base584 by bonding the cap to upper section 584 b. As shown in FIG. 19, abonding agent 589 is provided in a gap 590 between the upper section 584b of base 584 and the cylindrical wall 587 of the cap 585, with theinside face of the base section 588 of the cap in close proximity to theupper section 584 b. A heat shrink tubing 591 is optionally provided andshrunk down over the cylindrical wall 587 of the cap and over the basesection 584 a of the base working port base 584 in order to cover anyadhesive that may have extruded out from the gap 590 past the basesection 588 of the cap. Heat shrink tubing can also provide someintegrity to the port.

Working port 513 is also provided with a compression band 594 whichextends around the septum 586. The compression band 594 is preferablyadhered under tension to the septum 586 such that it imparts acontinuous radial compressive force on the septum denoted by arrows A,thereby keeping the septum closed when the endoscopic tool is removedfrom the port. The compression band 594 provides a closing force on theseptum which also prevents leakage from around the tool when the tooltraverses the septum.

The ports 100, 200, 300, 400, 500 of the embodiments as described hereinhave sidewalls which are frustoconical in shape. The sidewall (142, 242,342, 442, 542) of the respective port device as described hereinpreferably has a major outside diameter (measured at or near theperimeter of the top wall) in a range between 30-45 mm (most preferably35-40 mm) and tapers in diameter to a minor outside diameter (measuredat or near the distal opening 153, 253, 353, 453, 553) in a rangebetween 10-20 mm (most preferably 15 to 18 mm). The length of thesidewall (142, 242, 342, 442, 542) as measured from the center axis ofthe top wall to the center of the distal opening preferably has a rangefrom 40 to 60 mm; however, it can be cut to length in situ by thesurgeon, preferably at grooves 159, 259. Such configurations provide aslope angle α of the sidewall (142, 242, 342, 442, 542) in a rangebetween 5° and 20°, preferably 8°-12° (a 16° angle being shown in FIG.8). The wall thickness of the sidewall is sufficiently thick so that thewall will not readily buckle when placed in the umbilicus and whendilating the incision, yet sufficiently flexible to allow distortionwhen an instrument is forced against it. The sidewall (142, 242, 342,442, 542) is not meant to hug the instrumentation nor provide a sealagainst the instrumentation. Typical wall thicknesses are 0.5 mm to 3mm; preferably, 1 mm to 2 mm. If desired, the sidewall (142, 242, 342,442, 542) may be tapered in wall thickness with the sidewall adjacentthe top wall having a relatively larger thickness (e.g., 2 mm), and thesidewall near the distal opening being relatively thinner (e.g., 1 mm inthickness). Also, as shown in FIGS. 5, 8 and 10, if desired, thesidewall at the distal opening can taper sharply (shown as 222 a) downto a minimal thickness. With the frustoconical sidewall being tapered inthickness, the portion of the sidewall which is subject to the mostcompressive force in the umbilicus will not easily buckle, and at thesame time, as suggested by FIG. 20, the distal portion of the sidewallwill be more flexible to permit a wider freedom of movement to thelaparoscopic tools 264, 265 extending through the working ports of theport device. Further, as shown in FIGS. 5 to 8, when larger diameterports are used, the overall dimensions of the major outer diameter canbe increased 10% to 20% to fit these oversized ports. Similarly, inorder to retain the same slope angle of the sidewall, the length of thedevice can be increased proportionally. Still further, for pediatricapplications, the entire device may be reduced by approximately 50% inall dimensions. For example, the ports may be sized to accommodate 3 mmtools.

The port device 100, 200 as described herein can be made as a singleinjection molded piece in an injection or compression molding machine.As such, it is relatively inexpensive to make and is thereforedisposable. Similarly, port devices 300, 400 and 500 which includereinforcement plate and/or belts can be simply formed through insertmolding with the mold formed over the reinforcement plates or belts. Inthe case of port device 500, the cap is separately molded and thenattached by bonding agent. Likewise, the heat shrink tubing and thecompression band are separately formed and attached to the port device.

The ports of the present invention function as follows: First, anincision 10-25 mm wide is made in the umbilicus or elsewhere in the bodyusing the Hassan procedure. If entered into the abdominal cavity, theincision is continued through the fascia of the abdomen wall into theabdominal cavity. The narrow end of the tapered sidewall (142, 242, 342,442, 542) of the device is inserted into the incision and forceddownward such that the incision is stretched sufficiently by the taperedsidewall to engage the tissue and provide a seal between the tissue andthe tapered sidewall. If desired, the top wall of the port and workingports can remain above the skin, or if desired, for example for obesepatients, the entire device can be inserted below the skin with the sealformed in the fascia of the abdominal wall. The working ports, centralcavity and opening opposite the top wall of the port provide apassageway for three laparoscopic instruments (which have approximately5 mm or 10 mm or greater cannulas) to be inserted into the abdominalcavity. In addition, the insufflation port provides a means by which theabdominal cavity may be inflated. The port device may be sutured inplace if desired. An operation may then be conducted through the workingports. Upon conclusion of the operation, and if for example theoperation involved removal of an organ (e.g., infected gall bladder),the organ can be pulled into the hollow frustoconical structure, thesutures removed from the ears and the entire port with the organ housedin the hollow structure removed. In this manner the organ does not touchthe fascia or epidermis, which may otherwise result in infection of theincision site. Once the port is removed, the sutures can be further usedto close the incision in any manner known in the art. Alternatively, theport may be removed from the incision, the organ removed sequentiallyand the incision closed in any manner known in the art.

FIG. 20 shows the flexible disposable port 200 of FIGS. 5-8 placed in anincision in the umbilicus, comprised of epidermis 61 and fascia 62. Thetapered (frustoconical) sidewall 242 of the port 200 both seals theincision in the umbilicus such that gas used to inflate the abdominalcavity does not leak between the umbilicus and taper, and dilates theopening to allow a larger working area. If the surgeon so desires, thetapered sidewall 242 can be cut with a scissors or blade at thecircumferential rings 259 (FIG. 7) to shorten the tapered sidewall 242and to provide a wider area of unrestricted movement of the instruments.Instruments 264 and 265 are pierced through membranes 217 that cover theentrance to the working ports 213B and 213A, respectively. Theinstruments 264, 265 pass through the working ports 213B, 213A andtranscend the central cavity 252 defined by the tapered sidewall 242 andexit through the distal opening 253 into the abdominal space 72. Notethat the flexible tapered sidewall 242 is deformable about its distalportion to enable maneuvering of the instrumentation 264 and 265 over abroader area. The port 200 is held firmly in place by sutures 70 snaggedinto the slots 229 (FIG. 6) of the suture retention means 225 and sewninto the adjacent tissue. Note that relatively large organs can beremoved from the abdominal space 72 when the port 200 is removed fromthe umbilicus entrance site following completion of surgery. Forexample, a 30 mm diameter gall bladder may be removed from the umbilicusincision. Larger organs can be cut or morsellated and then removedthrough the opening. It should be appreciated that surgery through theumbilicus is less painful than surgery through other parts of theabdomen as there are fewer pain receptors as well as less muscle to cutthrough. Accordingly it also heals faster with less chance ofcomplication.

Other features can be added to the flexible surgical port device. Forexample, the flexible surgical port device can include a built-in lighton the inside of the device to illuminate the cavity. Luer fittings canbe added to the ports; especially the insufflation port. In addition,the flexible nature of each individual working port allows each workingport to be clamped with a hemostat to prevent deflation of the abdominalcavity if necessary. If required, each working port can be fitted with atethered stopper to enable plugging the working port when not in use.Further the working ports can be fabricated as bellows to facilitatemovement of the instruments and port stems. While the working ports 113,213, 313, 413, 513 have heights (lengths) of preferably between 8 and 12mm, it will be appreciated that the working ports may be extended to beeven longer to prevent interference of the laparoscopic tools.Alternatively, the ports can shorter or can be flush with the top wallof the device. In addition, the entire upper part of the device, can bemade from a material different from the frustoconical section andattached to the plate 480 by mechanical means of by chemical adhesivesand the like. The device can also have attachment means on the portentrances to allow attachment of caps that contain valves or blanksStill further, a section of material 441 (FIG. 17) in the center of theplate between the working channels 413, can be removed to expose theplate 480. If a clear material, such as polycarbonate, is used to formthe plate 480, then removing the material enables a clear window to beformed through the top of the port to enable direct visualization of theabdominal cavity.

The flexible disposable port devices described herein can be made fromany flexible elastomeric material, for example, silicone rubber,polyurethane, polyolefin (such as SIBS, SEBS, butyl rubber,polyisoprene, polybutadiene, etc.), polyvinylchloride, natural rubber,blends of two or more of listed material, and the like. SIBS is a blockcopolymer of styrene-block-isobutylene-block-styrene. SEBS is a blockcopolymer of styrene-block-ethylene-butylene-block-styrene.

The flexible elastomeric material preferably has a Durometer less thanShore 80A and greater than Shore 20A, and most preferably in a rangebetween Shore 65A and Shore 30A; preferably Shore 45A. The flexibleelastomeric material also preferably has a modulus of elasticity at 100%elongation (referred to herein as “Modulus@100%” greater than 0.5 Mpaand less than 2 MPa such that port device seals around umbilicalentrance site and the laparoscopic tools inserted therethrough as wellas provide for innocuous operation of the tool when it touches thedistal end of the tapered sidewall (FIG. 18). If the Modulus@100% isless than 0.5 Mpa, the tapered sidewall would buckle in the umbilicalentrance site. If the Modulus@100% is greater than 2 Mpa, the ports ofthe device will not easily and quickly seal around the tool(s) insertedtherethrough. The flexible elastomeric material also preferably has atensile strength of greater than 3 MPa, a percent of elongation at breakgreater than 600%, and a tear strength greater than 20 kN/m so as not totear after prolonged use in the body.

In the embodiments of FIGS. 1-4 and FIGS. 5-9, it is preferable that theentire device be made from one polymer and as one piece, either byinjection molding or compression molding. A filler (such as titaniumdioxide) can be added to the elastomeric material as needed to dictatethe color and transparency of the device.

In one embodiment, the flexible disposable port devices described hereinare made from SIBS. SIBS is realized from a triblock of polyisobutyleneand polystyrene (a block copolymer ofpoly(styrene-block-isobutylene-block-styrene)). Polyisobutylene (PIB) isa soft elastomeric material with a Shore hardness of approximately 10Ato 30A. When copolymerized with polystyrene, it can be made athardnesses ranging up to that of polystyrene having a Shore hardness of100D. Thus, depending on the relative amounts of polystyrene andpolyisobutylene, the SIBS material can have a range of hardnesses fromas soft as Shore 10A to as hard as Shore 100D. In this manner, the SIBSmaterial can be adapted to have elastomeric and hardness qualitiesdesirable for the flexible port devices as described herein. Details ofthe SIBS material is set forth in U.S. Pat. Nos. 5,741,331; 6,102,939;6,197,240; 6,545,097, which are hereby incorporated by reference intheir entireties. The SIBS material may be polymerized in a controlledmanner using carbocationic polymerization techniques such as thosedescribed in U.S. Pat. Nos. 4,276,394; 4,316,973; 4,342,849; 4,910,321;4,929,683; 4,946,899; 5,066,730; 5,122,572; and Re 34,640, each hereinincorporated by reference in their entireties. The amount of styrene inthe copolymer material is preferably between 10 mole % and 25 mole % andmost preferably between 17 mole % and 22 mole %. The polystyrene andpolyisobutylene copolymer materials are preferably copolymerized insolvents.

Alternative polymeric materials can be used for the device. Suchalternative polymeric materials may include polyisobutylene-basedmaterial capped with a glassy segment. The glassy segment provides ahardener component for the elastomeric polyisobutylene. The glassysegment can be a vinyl aromatic polymer (such as styrene,α-methylstyrene, or a mixture thereof), or a methacrylate polymer (suchas methylmethacrylate, ethylmethacrylate, hydroxymethalcrylate, or amixture thereof). Such materials preferably have a general blockstructure with a central elastomeric polyolefinic block andthermoplastic end blocks. Such materials may have a general structure:

-   -   BAB or ABA (linear triblock),    -   B(AB)_(n) or a(BA)_(n) (linear alternating block), or    -   X-(AB)_(n) or X-(BA)_(n) (includes diblock, triblock and other        radial block copolymers), where A is an elastomeric polyolefinic        block, B is a thermoplastic block, n is a positive whole number        and X is a starting seed molecule.

Such materials may be star-shaped block copolymers (where n=3 or more)or multi-dendrite-shaped block copolymers. These materials collectivelybelong to the polymeric material referred to herein as SIBS.

Forming the port devices as described herein from SIBS affords theadvantages of superb biocompatibility and biostability characteristics,ease of injection molding, ease of insert molding (particularly forinsert molding the reinforcement band or reinforcement plate asdescribed herein), ease of solvent bonding (for example, bonding valvesto the ports of the device), accurate control over the Durometer of thematerial over the required range of Durometer (e.g., between Shore 80Aand Shore 20A), providing a Modulus@100% within the preferred rangebetween 0.5 Mpa and 2 MPa, and providing tensile characteristics(tensile strength, percent of elongation at break, and tear strength)that minimizes tearing of the port device after prolonged use in thebody.

A presently preferred thermoplastic elastomeric material for use inmaking the port body is a polyurethane blended with a polyolefin (e.g.,polybutadiene) which is available from RTP Co., Winona, Minn. under thetradename RTP-6003-45A. A similar material (polyurethane blended withpolybutadiene) is available from New England Urethane, Inc., NorthHaven, Conn. under the tradename Neusoft 596-50. The presently preferredmaterials have the distinct advantage that in addition to theirstrength, softness, and elongation characteristics, they surprisingly donot readily absorb body fat so that they resist softening and tearing inthe body and can be used with mineral oil-based lubricants. They alsoprovide ease of injection molding, ease of insert molding (particularlyfor insert molding the reinforcement band or reinforcement plate asdescribed herein), ease of bonding (for example, bonding valves to theports of the device or bonding port caps to the ports), accurate controlover the Durometer of the material over the required range of Durometer(e.g., between Shore 80A and Shore 20A), providing a Modulus@100% withinthe preferred range between 0.5 Mpa and 2 MPa, and providing tensilecharacteristics (tensile strength, percent of elongation at break, andtear strength) that minimizes tearing of the port device after prolongeduse in the body.

For purposes of the presently preferred embodiment, a presentlypreferred material for the port cap is polyisoprene or a platinumcatalyzed liquid silicone rubber (LSR), which is preferably bonded tothe port body by a silicone adhesive. A presently preferred material forthe compression band around the port cap is platinum catalyzed liquidsilicone rubber which is bonded to the port cap with a siliconeadhesive. A presently preferred material for the heat shrink tubing isone that has minimal extractables in mineral oil and will passbiocompatibility testing required by the FDA, such as fluorocarbons,crosslinked polyolefins, Nylon and the like.

Table 1 below illustrates the properties of RTP 6003-45A and threedifferent grade SIBS as compared to other flexible elastomeric materialsfor the port body, with the silicone (NuSil MED 4940) being the LSRwhich is presently preferably for the port cap.

TABLE 1 Material SEPS SEBS RTP 6003 SIBS (073T) SIBS (103T) SIBS (102T)(styrene SBS (styrene Property Blend of 20 mole % styrene, 20 mole %styrene, 8 mole % styrene, ethylene- (styrene ethylene- Propertypolyurethane molecular weight of molecular weight of molecular weight ofSilicone propylene butadiene butylene Name Unit and polyolefin ~70,000Dalton ~100,000 Dalton ~100,000 Dalton (4940) styrene) styrene) styrene)Hardness Shore 45 45-47 46-50 25-30 40 80 70 77 A Modulus MPa 1.3 0.91.0 0.5-0.7 2 3.7 2.0 2.4 at 100% Tensile MPa 4 14 18 16 7.6 42 31 34Strength at break % % 900 650 620 870 550 480 860 500 Elongation atbreak Tear KN/m 21 26 38 25 44 46 47 44 Strength

According to one aspect of the invention, it was determined that SIBSdoes not require lubrication of the ports (or of the instrumentsextending through the ports) to enable better sliding of theinstrumentation in the respective ports. More particularly, as shown inFIG. 21, upon initial tool insertion into SIBS ports withoutlubrication, a relatively large force is required, but thereafter therequired insertion force of the non-lubricated SIBS port is similar to alubricated port. By avoiding the need for such lubrication, the risk ofinfection stemming from such lubrication is avoided. This feature wasunexpected and provides significant advantages. Moreover, it iscontemplated that an instrument can be inserted into the non-lubricatedSIBS port one or more times at the time of manufacture (or at the timeof distribution or prior to use) such the surgeon does not experiencethe large initial insertion force of the non-lubricated SIBS port. Thosewell versed in the art will understand that the sliding forces of theinstrument through the port are a function of the material, thelubricity and the design of the port. For example, if the port is asimple slit, the length of the slit will contribute to the overall forcerequired to insert a tool. For example if the slit is long, e.g., 0.25″(6.35 mm) long, the force required to insert a 5 mm diameter tool willbe low, but the leakage rate of gas around the tool may be too high.Alternatively, if the slit is 0.125″ long (3.15 mm), the leakage ratewill be zero but the tool will not slide as easily. With a slit lengthof 0.1875″ (4.8 mm), the leakage rate is approximately zero with easyslidability. It is desirable during laparoscopic surgery that the flowrate of carbon dioxide be set at 9-15 L/min which provides a pressure inthe abdominal cavity of approximately 12-15 mmHg. The port constructionshould be such that the pressure drop during a procedure should be lessthan 3 mmHg.

In yet other embodiments, the flexible elastomeric material from whichthe port devices as described herein are formed can contain fillers suchas Teflon particles or oils to lubricate the ports to enable bettersliding of the instrumentation in the respective ports. The device canalso be made with slippery surfaces (hydrophilic or hydrophobic) tofacilitate sliding of the instrument in the ports. Also, althoughsutures and suture snaggers, both rigid and flexible, are shown to holdthe port in place, a belt placed around the abdomen of the patient thatcontains the port device of the invention will accomplish the same. Inaddition, the tapered outer surface can be made sticky to decreasesliding, or a flange can be added to the proximal end with an adhesiveon the inner surface to further aid in maintaining the port in place.

In accordance with another aspect of the invention, the side wall couldbe stepped so that it is generally frustoconical (e.g., it has severalfrustoconical sections). The side wall could also be stepped or threadedwith a helical interface to enable the sidewall to be screwed into theincision. In accord with a further aspect of the invention, thethickness of the frustoconical side wall could change in steps orgradually over the length of the port device. In accordance with anadditional aspect of the invention, rather than having ports extendingoutward from the top wall, no outwardly extending ports are provided,and the ports consist of holes in the top wall of the port device.Alternatively, the ports can extend slightly inside the frustoconicalouter wall. Finally, instead of three working ports and an optionalinsufflation port, a different number of working ports (e.g., four) canbe provided. Those skilled in the art will understand that othermodifications to this device can be made without deterring from thescope of this invention.

There have been described and illustrated herein several embodiments ofa flexible elastomeric surgical port device and surgical method of usingsame. While particular embodiments of the invention have been described,it is not intended that the invention be limited thereto, as it isintended that the invention be as broad in scope as the art will allowand that the specification be read likewise. Thus, while particularflexible elastomeric materials have been disclosed, it will beappreciated that other elastomeric materials can be used as well. Inaddition, while particular port and valve configurations have beendisclosed, it will be understood that other suitable port and valveconfigurations can be used. Moreover, while particular configurationshave been disclosed in reference to integrated reinforcement of the portbody, it will be appreciated that other configurations could be used aswell. It will therefore be appreciated by those skilled in the art thatyet other modifications could be made to the provided invention withoutdeviating from its spirit and scope as claimed.

1. A surgical apparatus for introduction of laparoscopic instrumentsinto an anatomical cavity through tissue at an entry site, saidapparatus comprising: a one-piece molded body with afrustoconical-shaped wall with an exterior sealing surface for sealablecontact with the tissue at the entrance site, the body defining aninterior cavity, an open bottom, and a substantially closed top wallwith openings from which a plurality of ports extend upward therefrom,the plurality of ports for receiving the laparoscopic instruments forintroduction through the interior cavity and open bottom of the bodyinto the anatomical cavity.
 2. A surgical apparatus according to claim1, further comprising: suture retention means for suturing the body totissue adjacent the entry site.
 3. A surgical apparatus according toclaim 2, wherein: the suture retention means are disposed within theradial periphery of the top wall of the body.
 4. A surgical apparatusaccording to claim 2, wherein: the suture retention means is integrallyformed on a top surface of the top wall of the body about the perimeterof the top wall of the body.
 5. A surgical apparatus according to claim2, wherein: the suture retention means is integrally formed as part of aplate that covers the top wall of the body and is disposed about theperimeter of the top wall of the body, the plate having thru-holes foraccommodating the plurality of ports that extend therethrough.
 6. Asurgical apparatus according to claim 2, wherein: the suture retentionmeans is integrally formed as part of a plate that is disposed under thetop wall of the body and that extends radially outward beyond thefrustoconical-shaped wall of the body.
 7. A surgical apparatus accordingto claim 1, further comprising: reinforcement means for reinforcing thebody such that the frustoconical-shaped wall maintain its shape wheninserted through tissue at the entry site.
 8. A surgical apparatusaccording to claim 7, wherein: the reinforcement means comprises amember that is integrally formed with the molded body by insert molding.9. A surgical apparatus according to claim 7, wherein: the reinforcementmeans comprises a band that extends about the frustoconical-shaped wall.10. A surgical apparatus according to claim 7, wherein: thereinforcement means comprising a plate that is integrally formed withtop wall of the body.
 11. A surgical apparatus according to claim 10,wherein: the plate includes integrally formed suture retention meansthat extend radially outward beyond the frustoconical-shaped wall of thebody, the suture retention means for suturing the body to tissueadjacent the entry site.
 12. A surgical apparatus according to claim 10,wherein: the plate includes a plurality of thru-holes corresponding tothe ports of the body, each thru-hole sized to match the correspondingport.
 13. A surgical apparatus according to claim 12, wherein: the plateprovides a pivot point for pivoting movement of the laparoscopicinstruments extending therethrough.
 14. A surgical apparatus accordingto claim 12, wherein: the plate includes at least one thru-hole thatallows for inflow of material during insert molding of the body.
 15. Asurgical apparatus according to claim 10, wherein: the plate comprises amaterial selected from the group including a metal, polyoxymethylene,polycarbonate, polyurethane, and poly(acrylonitrile-butadiene-styrene).16. A surgical apparatus according to claim 1, wherein: the body isformed from a material having a Hardness of between 30A and 65A, atensile strength of greater than 3 MPa, a tear strength of greater than20 KN/m, and an elongation percentage at break of greater than 600%. 17.A surgical apparatus according to claim 1, wherein: thefrustoconical-shaped wall of the body has spaced circumferential groovesfor assisting cutting or trimming to a desired length.
 18. A surgicalapparatus according to claim 1, wherein: the interior cavity of the bodyis adapted to receive an organ for removal from the anatomical cavitywithout contacting the tissue at the entry site.
 19. A surgicalapparatus according to claim 1, further comprising: a plurality of portcaps, respective of said plurality of port caps extending overrespective of said plurality of ports.
 20. A surgical apparatusaccording to claim 19, wherein: said port caps include a cylindricalwall and a top septum.
 21. A surgical apparatus according to claim 20,wherein: said top septum defines a central well where said septum has areduced thickness.
 22. A surgical apparatus according to claim 21,wherein: said top septum has a slit extending entirely through saidseptum at said location of said central well.
 23. A surgical apparatusaccording to claim 20, further comprising: a compressive band locatedabout said top septum.
 24. A surgical apparatus according to claim 23,wherein: said top septum has a slit therein, and said compressive bandacts to keep said slit closed.
 25. A surgical apparatus according toclaim 20, wherein: each of said plurality of ports has a base sectionadjacent said top wall having a first thickness and an upper sectionhaving a reduced thickness relative to said first thickness, and saidcylindrical wall of each of said plurality of port caps extends aboutsaid upper section.
 26. A surgical apparatus according to claim 25,wherein: said cylindrical wall for a respective port cap is bonded tosaid upper section of a respective port.
 27. A surgical apparatusaccording to claim 26, further comprising: a heat shrink tube extendingover each said cylindrical wall and at least a portion of each port basesection.
 28. A surgical apparatus according to claim 19, wherein: saidplurality of port caps are formed from silicone rubber, and said moldedbody is formed from a polyurethane blended with a polyolefin and havinga Hardness of between 30A and 65A, a tensile strength of greater than 3MPa, a tear strength of greater than 20 KN/m, and an elongationpercentage at break of greater than 600%.
 29. A surgical apparatus forintroduction of laparoscopic instruments into an anatomical cavitythrough tissue at an entry site, said apparatus comprising: a body witha frustoconical-shaped wall with an exterior sealing surface forsealable contact with the tissue at the entrance site, the body definingan interior cavity, an open bottom, and a substantially closed top wallwith openings from which a plurality of ports extend upward therefrom,the plurality of ports for receiving the laparoscopic instruments forintroduction through the interior cavity and open bottom of the bodyinto the anatomical cavity, wherein the body is formed from a materialhaving a Hardness of between 30A and 65A, a tensile strength of greaterthan 3 MPa, a tear strength of greater than 20 KN/m, and an elongationpercentage at break of greater than 600%.
 30. A surgical apparatusaccording to claim 29, wherein: the body is unitary one-piece moldedstructure.